Vascular Access Registry

NCT06942260 | Recruiting

• 1 other identifier: 362/05.09.2024
• Study Type: observational
• Target: 1,157
• Locations: 1 country
• Sites: 1

Brief Summary

The Vascular Access Registry (VARegistry) is a prospective patient registry that will be conducted at the Hemodynamic Laboratory of the Cardiology Clinic of the University General Hospital of Patras. The puncture of the vessel will be performed either using palpation, anatomical landmarks or using ultrasound guidance, depending on the ability and preference of each operator. Patients who meet all admission criteria and no exclusion criteria will be admitted to the study. Patients \>18 years of age presented with indication for any percutaneous cardiac procedure will be included in the study. No exclusion criteria exist. The vascular puncture will be performed according to current guidelines and on the basis of recent scientific data. If the attempt to obtain access from the selected location is unsuccessful, the access location will be changed. The choice of the new access location in case of failure of the originally selected one is subject to the preference of each operator. Participants will be monitored for the period they remain hospitalized, depending on the initial indication of intervention, and a follow-up with a vascular ultrasound after one month is recommended. The primary endpoint is the percentage of success of the puncture at the initial access point. The secondary endpoints are as follows:

• Percentages of successful puncture of vascular access with and without the use of ultrasound guidance
• Occlusion rate of the access artery before discharge
• Crossover rate of access site during procedure
• Time to sheath placement during procedure
• Total intervention time
• Procedure duration (from the sheath insertion to the completeness of the procedure)
• Total fluoroscopy time
• Total DAP (Dose area product)
• Air Kerma
• Time required for hemostasis
• Vascular complications \*
• Classification of hematomas (modified classification by EASY)\*\*
• Vascular implication of access artery using ultrasound monitoring of patients at 30 days
• VARC criteria \*\* if the forearm has been used

Conditions

Vascular Access; Coronary Interventions

Keywords

Vascular Access; Coronary Interventions; Coronary Angiography; Radial Artery; Distal Radial Artery

Outcome Measures

Primary Outcomes (1)

• Percentage of success of the puncture at the initial access point

  From puncture of access site until successful sheath insertion

Secondary Outcomes (13)

• Percentages of successful puncture of vascular access with and without the use of ultrasound guidance

  Until successful sheath insertion

• Occlusion rate of the access artery before discharge

  From the completion of procedure until hospital discharge

• Crossover rate of access site during the procedure

  From first puncture of primary access site until successful sheath insertion

• Time to sheath placement

  From first puncture of primary access site until successful sheath insertion

• Total intervention time

  From first puncture of primary access site until successful completion of the procedure

Study Arms (6)

Radial Artery Approach

Distal Radial Artery Approach

Femoral Artery Approach

Ultrasound-Guided Radial Artery Approach

Ultrasound-Guided Distal Radial Artery Approach

Ultrasound-Guided Femoral Artery Approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients \>18 years of age presented with indication for any percutaneous cardiac procedure will be included in the study.

You may qualify if:

• Indication for percutaneous cardiac procedure

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

Cardiology Department, University Hospital of Patras

Pátrai, ACHAIA, 26500, Greece

RECRUITING

Related Publications (24)

• Mason PJ, Shah B, Tamis-Holland JE, Bittl JA, Cohen MG, Safirstein J, Drachman DE, Valle JA, Rhodes D, Gilchrist IC; American Heart Association Interventional Cardiovascular Care Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Peripheral Vascular Disease; and Council on Genomic and Precision Medicine. An Update on Radial Artery Access and Best Practices for Transradial Coronary Angiography and Intervention in Acute Coronary Syndrome: A Scientific Statement From the American Heart Association. Circ Cardiovasc Interv. 2018 Sep;11(9):e000035. doi: 10.1161/HCV.0000000000000035.

  PMID: 30354598 BACKGROUND

• Tsigkas G, Moulias A, Papageorgiou A, Ntouvas I, Grapsas N, Despotopoulos S, Apostolos A, Papanikolaou A, Smaili K, Vasilagkos G, Davlouros P, Hahalis G. Transradial access through the anatomical snuffbox: Results of a feasibility study. Hellenic J Cardiol. 2021 May-Jun;62(3):201-205. doi: 10.1016/j.hjc.2020.02.002. Epub 2020 Mar 2.

  PMID: 32135274 BACKGROUND

• Didagelos M, McEntegart M, Kouparanis A, Tsigkas G, Koutouzis M, Tsiafoutis I, Kassimis G, Oldroyd KG, Ziakas A. Distal Transradial (Snuffbox) Access for Coronary Catheterization: A Systematic Review. Cardiol Rev. 2021 Jul-Aug 01;29(4):210-216. doi: 10.1097/CRD.0000000000000339.

  PMID: 34061817 BACKGROUND

• Sgueglia GA, Hassan A, Harb S, Ford TJ, Koliastasis L, Milkas A, Zappi DM, Navarro Lecaro A, Ionescu E, Rankin S, Said CF, Kuiper B, Kiemeneij F. International Hand Function Study Following Distal Radial Access: The RATATOUILLE Study. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1205-1215. doi: 10.1016/j.jcin.2022.04.023. Epub 2022 May 17.

  PMID: 35595672 BACKGROUND

• Sgueglia GA, Lee BK, Cho BR, Babunashvili A, Lee JB, Lee JW, Schenke K, Lee SY, Harb S. Distal Radial Access: Consensus Report of the First Korea-Europe Transradial Intervention Meeting. JACC Cardiovasc Interv. 2021 Apr 26;14(8):892-906. doi: 10.1016/j.jcin.2021.02.033.

  PMID: 33888235 BACKGROUND

• Eid-Lidt G, Rivera Rodriguez A, Jimenez Castellanos J, Farjat Pasos JI, Estrada Lopez KE, Gaspar J. Distal Radial Artery Approach to Prevent Radial Artery Occlusion Trial. JACC Cardiovasc Interv. 2021 Feb 22;14(4):378-385. doi: 10.1016/j.jcin.2020.10.013.

  PMID: 33602433 BACKGROUND

• Tsigkas G, Papageorgiou A, Moulias A, Kalogeropoulos AP, Papageorgopoulou C, Apostolos A, Papanikolaou A, Vasilagkos G, Davlouros P. Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center, Randomized Study. JACC Cardiovasc Interv. 2022 Jan 10;15(1):22-32. doi: 10.1016/j.jcin.2021.09.037. Epub 2021 Dec 15.

  PMID: 34922888 BACKGROUND

• Tsigkas G, Papageorgiou A, Moulias A, Apostolos A, Kalogeropoulos AP, Davlouros P. Reply: Distal Transradial Access for Primary PCI in ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Interv. 2022 Apr 11;15(7):795-796. doi: 10.1016/j.jcin.2022.02.039. No abstract available.

  PMID: 35393114 BACKGROUND

• Aminian A, Sgueglia GA, Wiemer M, Kefer J, Gasparini GL, Ruzsa Z, van Leeuwen MAH, Ungureanu C, Leibundgut G, Vandeloo B, Kedev S, Bernat I, Ratib K, Iglesias JF, Al Hage E, Posteraro GA, Pascut D, Maes F, Regazzoli D, Kakonyi K, Meijers TA, Colletti G, Krivoshei L, Lochy S, Zafirovska B, Horak D, Nolan J, Degrauwe S, Tobita K, Saito S. Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1191-1201. doi: 10.1016/j.jcin.2022.04.032. Epub 2022 May 17.

  PMID: 35595673 BACKGROUND

• Le May M, Wells G, So D, Chong AY, Dick A, Froeschl M, Glover C, Hibbert B, Marquis JF, Blondeau M, Osborne C, MacDougall A, Kass M, Paddock V, Quraishi A, Labinaz M. Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The SAFARI-STEMI Randomized Clinical Trial. JAMA Cardiol. 2020 Feb 1;5(2):126-134. doi: 10.1001/jamacardio.2019.4852.

  PMID: 31895439 BACKGROUND

• Valgimigli M, Frigoli E, Leonardi S, Vranckx P, Rothenbuhler M, Tebaldi M, Varbella F, Calabro P, Garducci S, Rubartelli P, Briguori C, Ando G, Ferrario M, Limbruno U, Garbo R, Sganzerla P, Russo F, Nazzaro M, Lupi A, Cortese B, Ausiello A, Ierna S, Esposito G, Ferrante G, Santarelli A, Sardella G, de Cesare N, Tosi P, van 't Hof A, Omerovic E, Brugaletta S, Windecker S, Heg D, Juni P; MATRIX Investigators. Radial versus femoral access and bivalirudin versus unfractionated heparin in invasively managed patients with acute coronary syndrome (MATRIX): final 1-year results of a multicentre, randomised controlled trial. Lancet. 2018 Sep 8;392(10150):835-848. doi: 10.1016/S0140-6736(18)31714-8. Epub 2018 Aug 25.

  PMID: 30153988 BACKGROUND

• Xie L, Wei X, Xie Z, Jia S, Xu S, Wang K. Feasibility of Distal Radial Access for Coronary Angiography and Percutaneous Coronary Intervention: A Single Center Experience. Cardiology. 2021;146(5):531-537. doi: 10.1159/000517076. Epub 2021 Aug 6.

  PMID: 34365454 BACKGROUND

• Kim Y, Lee JW, Lee SY, Bae JW, Lee SJ, Jeong MH, Lee SH, Ahn Y. Feasibility of primary percutaneous coronary intervention via the distal radial approach in patients with ST-elevation myocardial infarction. Korean J Intern Med. 2021 Mar;36(Suppl 1):S53-S61. doi: 10.3904/kjim.2019.420. Epub 2020 Mar 3.

  PMID: 32122114 BACKGROUND

• Lee OH, Kim Y, Son NH, Roh JW, Im E, Cho DK, Choi D. Comparison of Distal Radial, Proximal Radial, and Femoral Access in Patients with ST-Elevation Myocardial Infarction. J Clin Med. 2021 Aug 2;10(15):3438. doi: 10.3390/jcm10153438.

  PMID: 34362221 BACKGROUND

• Neumann F-J, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. England; 2019;40:87-165.

  BACKGROUND

• Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Soci. Eur Heart J. England; 2018;39:119-77.

  BACKGROUND

• Elmahdy MF, ElMaghawry M, Hassan M, Kassem HH, Said K, Elfaramawy AA. Comparison of Safety and Effectiveness Between Right Versus Left Radial Arterial Access in Primary Percutaneous Coronary Intervention for Acute ST Segment Elevation Myocardial Infarction. Heart Lung Circ. 2017 Jan;26(1):35-40. doi: 10.1016/j.hlc.2016.04.021. Epub 2016 May 25.

  PMID: 27374862 BACKGROUND

• Hamilton GW, Sharma V, Yeoh J, Yudi MB, Raman J, Clark DJ, Farouque O. Ultrasound Guidance for Transradial Access in the Cardiac Catheterisation Laboratory: A Systematic Review of the Literature and Meta-Analysis. Heart Lung Circ. 2024 Oct;33(10):1404-1413. doi: 10.1016/j.hlc.2024.04.308. Epub 2024 Jun 12.

  PMID: 38871531 BACKGROUND

• Soydan E, Akin M. Left Distal Radial Artery Access Site in Primary Percutaneous Coronary Intervention: Is It Safe? Balkan Med J. 2020 Aug 11;37(5):276-280. doi: 10.4274/balkanmedj.galenos.2020.2020.4.49. Epub 2020 Jun 4.

  PMID: 32495613 BACKGROUND

• Oliveira MD, Navarro EC, Caixeta A. Distal transradial access for coronary procedures: a prospective cohort of 3,683 all-comers patients from the DISTRACTION registry. Cardiovasc Diagn Ther. 2022 Apr;12(2):208-219. doi: 10.21037/cdt-21-542.

  PMID: 35433348 BACKGROUND

• Oliveira MDP, Navarro EC, Kiemeneij F. Distal transradial access as default approach for coronary angiography and interventions. Cardiovasc Diagn Ther. 2019 Oct;9(5):513-519. doi: 10.21037/cdt.2019.09.06.

  PMID: 31737522 BACKGROUND

• Tsigkas G, Apostolos A, Davlouros P. Less Is More, But Not Always: Distal Transradial Access for Radial Artery Occlusion Prevention. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1202-1204. doi: 10.1016/j.jcin.2022.05.001. Epub 2022 May 17. No abstract available.

  PMID: 35583362 BACKGROUND

• Ziakas A, Didagelos M, Hahalis G, Koutouzis M, Tsigkas G, Bompotis G, Toutouzas K, Kartalis A, Hamilos M, Kouparanis A, Sanidas E, Skalidis I, Papadopoulos T, Katranas S, Tsioufis K, Karvounis H. Characteristics of the transRADIAL approach for coronary angiography and angioplasty in GREECE: the RADIAL-GREECE registry. Hellenic J Cardiol. 2018 Jan-Feb;59(1):52-56. doi: 10.1016/j.hjc.2017.07.009. Epub 2017 Aug 12. No abstract available.

  PMID: 28807802 BACKGROUND

• Hahalis G, Tsigkas G, Kakkos S, Panagopoulos A, Tsota I, Davlouros P, Xanthopoulou I, Koniari I, Grapsas N, Christodoulou I, Almpanis G, Leopoulou M, Kounis N, Alexopoulos D. Vascular Complications Following Transradial and Transulnar Coronary Angiography in 1600 Consecutive Patients. Angiology. 2016 May;67(5):438-43. doi: 10.1177/0003319715592095. Epub 2015 Jun 29.

  PMID: 26124493 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiology

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 24, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

GR (1)